Spinal Manipulation Compared with Back School
and with Individually Delivered Physiotherapy
for the Treatment of Chronic Low Back Pain:
A Randomized Trial with One-year Follow-upThis section is compiled by Frank M. Painter, D.C.
Send all comments or additions to: Frankp@chiro.org
FROM: Clinical Rehabilitation 2010 (Jan); 24 (1): 26–36 ~ FULL TEXT
Francesca Cecchi, Raffaello Molino-Lova, Massimiliano Chiti,
Guido Pasquini, Anita Paperini, Andrea A Conti, and Claudio Macchi
Fondazione Don Carlo Gnocchi,
Scientific Institute,
Florence, Italy.
FROM: Health Insights Today
A randomized trial by researchers at an outpatient rehabilitation department in Italy involving 210 patients with chronic, nonspecific low back pain compared the effects of spinal manipulation, physiotherapy and back school. The participants were 210 patients (140 women and 70 men) with chronic, non-specific low back pain, average age 59. Back school and individual physiotherapy were scheduled as 15 1-hour-sessions for 3 weeks. Back school included group exercise and education/ergonomics. Individual physiotherapy included exercise, passive mobilization and soft-tissue treatment. Spinal manipulation included 4-6 20-minute sessions once-a-week.
Outcome measures were the Roland Morris Disability Questionnaire (scoring 0-24) and Pain Rating Scale (scoring 0-6), assessed at baseline, discharge, and at 3, 6, and 12 months. 205 patients completed the study.
At discharge, disability score decreased by:3.7 +/- 4.1 for back school,
4.4 +/- 3.7 for individual physiotherapy, and
6.7 +/- 3.9 for manipulation.The pain score reduction was 0.9 +/- 1.1, 1.1 +/- 1.0, 1.0 +/- 1.1, respectively. At 12 months, disability score reduction was 4.2 +/- 4.8 for back school, 4.0 +/- 5.1 for individual physiotherapy, 5.9 +/- 4.6 for manipulation; pain score reduction was 0.7 +/- 1.2, 0.4 +/- 1.3, and 1.5 +/- 1.1, respectively.
Spinal manipulation was associated with higher functional improvement and long-term pain relief than back school or individual physiotherapy, but received more further treatment at follow-ups; pain recurrences and drug intake were also reduced compared to back school or individual physiotherapy.The difference in their improved scores is quite dramatic:
Intervention Disability Score Pain Rating At Discharge Spinal Manipulation 6.7 +/- 3.9 1.0 +/- 1.1 Individual Physiotherapy 4.4 +/- 3.7 1.1 +/- 1.0 Back School 3.7 +/- 4.1 0.9 +/- 1.1 After 12 months Spinal Manipulation 5.9 +/- 4.6 1.5 +/- 1.1 Individual Physiotherapy 4.0 +/- 5.1 0.4 +/- 1.3 Back School 4.2 +/- 4.8 0.7 +/- 1.2
NOTE: These numbers indicate the reductions in scores on the Roland Morris
Disability Questionnaire and the Pain Rating Scale.
OBJECTIVE: To compare spinal manipulation, back school and individual physiotherapy in the treatment of chronic low back pain.
DESIGN: Randomized trial, 12-month follow-up.
SETTING: Outpatient rehabilitation department.
PARTICIPANTS: 210 patients with chronic, non-specific low back pain, 140/210 women, age 59 +/- 14 years.
INTERVENTIONS: Back school and individual physiotherapy scheduled 15 1-hour-sessions for 3 weeks. Back school included: group exercise, education/ ergonomics; individual physiotherapy: exercise, passive mobilization and soft-tissue treatment. Spinal manipulation, given according to Manual Medicine, scheduled 4 to 6 20'-sessions once-a-week.
OUTCOME: Roland Morris Disability Questionnaire (scoring 0-24) and Pain Rating Scale (scoring 0-6) were assessed at baseline, discharge 3, 6, and 12 months.
RESULTS: 205 patients completed the study. At discharge, disability score decreased by 3.7 +/- 4.1 for back school, 4.4 +/- 3.7 for individual physiotherapy, 6.7 +/- 3.9 for manipulation; pain score reduction was 0.9 +/- 1.1, 1.1 +/- 1.0, 1.0 +/- 1.1, respectively. At 12 months, disability score reduction was 4.2 +/- 4.8 for back school, 4.0 +/- 5.1 for individual physiotherapy, 5.9 +/- 4.6 for manipulation; pain score reduction was 0.7 +/- 1.2, 0.4 +/- 1.3, and 1.5 +/- 1.1, respectively. Spinal manipulation was associated with higher functional improvement and long-term pain relief than back school or individual physiotherapy, but received more further treatment at follow-ups (P < 0.001); pain recurrences and drug intake were also reduced compared to back school (P < 0.05) or individual physiotherapy (P < 0.001).
CONCLUSIONS: Spinal manipulation provided better short and long-term functional improvement, and more pain relief in the follow-up than either back school or individual physiotherapy.
From the Full-Text Article:
Introduction
The treatment for chronic low back pain is still very controversial. Many interventions, including back school, education, specific exercise and spinal manipulation are claimed to be effective in the short term, but there is insufficient evidence that these approaches provide long-term effects on pain and function. [1]
Exercise therapy is a generally recommended treatment for chronic low back pain, but the most effective exercise approach is still under discussion; a recent review suggests that individually designed supervised exercise programmes, including stretching or strengthening, may provide more functional improvement and pain relief than home exercise in chronic non-specific low back pain. [2] Back school was first developed in Sweden in 1969, [3] conveying group back exercises with patient information/education and ergonomic training aimed at optimizing functional recovery. Since then, many different models of back school have been proposed and a recent Cochrane review concludes that there is moderate evidence that back school has better effects on pain and functional status than other treatments for patients with recurrent and chronic low back pain in the short and intermediate term. [4]
Individually delivered physiotherapy sometimes combined with individually tailored, active exercise, with passive or assisted mobilization or with manual treatment, is another widely adopted approach to the treatment of chronic low back pain. Different protocols and types of exercise may be involved in the delivery of such treatment, but the overall effectiveness and cost-effectiveness of this one-to-one approach are under question. [2, 5, 6]
Spinal manipulation and vertebral mobilization are also widely used in clinical practice, and there is evidence of the effectiveness of spinal manipulation both in the acute and in the subacute or chronic phase of low back pain. [7, 8] Nevertheless, it is not clear whether this intervention is more effective than anti-inflammatory drugs in reducing low back pain, [9] and there is no evidence that spinal manipulation therapy is superior to other standard treatments for patients with acute or chronic low back pain. [10] Many experts agree that there are more similarities than differences in the package of techniques used by professionals who deliver spinal manipulation. [11] Manual medicine [12] is a relatively recent discipline, based on a reproducible semiotics and a defined protocol of interventions. Although it is widely diffused in Europe, published evidence is scant. [13]
This paper presents a pragmatic clinical study conducted on patients with chronic non-specific low back pain. Our objective was to compare the short- and long-term effects of back school, individual physiotherapy and spinal manipulation, delivered according to manual medicine, with low back pain-related disability as our primary outcome.
Discussion
In this pragmatic clinical study we compared the short- and long-term effects of three recommended treatments for chronic, non-specific low back pain in a selected outpatient population. Spinal manipulation provided more functional improvement than either physiotherapy intervention, at discharge and all across follow-ups. Further, pain relief at follow-ups was also significantly more relevant in spinal manipulation patients. Low back pain recurrences and reduction of pain-related use of drugs were also most striking for the spinal manipulation group.
On the other hand, patients who underwent spinal manipulation were more prone to receive further care in the follow-up, even in the case of rare recurrences of low back pain. Treatment in most cases consisted of a short cycle of spinal manipulation. Though all patients received standardized education and advice to stay active, these results suggest that spinal manipulation may have been less effective than physiotherapy in promoting self-management of recurrences, [21] while the better pain control in this group compared with either back school or individual physiotherapy seemed to be obtained by more than occasional return to treatment in the long term. However, reasons for seeking and getting further care may be different, such as the requirement for a medical prescription, prompt availability of the required treatment, direct or indirect cost of the treatment, and the patient’s characteristics, including outdoor mobility and transport availability, which we did not investigate in detail.
The individual physiotherapy approach provided a similar outcome in the short term to the group physiotherapy approach represented by back school, but more individually treated patients reported recurrence of frequent-constant low back pain in the follow-up, and this difference from the back school group reached significance at 3 and 6 months from baseline. Thus back school provided a similar and, for some results, even better outcome than individual physiotherapy. Indeed, though emphasis on active self-treatment was given in both interventions, as well as a discharge home exercise programme, we hypothesize that the educational, more function-centred approach of back school was more effective in actually promoting self-treatment and compliance to a home programme. [2, 22] Furthermore, it is possible that the manual treatment and personal assistance received in individual treatment were actually more valued by individual physiotherapy patients than active exercise. This hypothesis would also explain why outcome differences developed in the follow-up, since the effects of motivation tend to become more evident in the long term. [23] Unfortunately, our observer-blind study design precluded the possibility of investigating compliance to home exercise in either physiotherapy group.
Because our patients could not be blinded and the spinal manipulation was given by a physician while the other interventions by a physiotherapist, a patient’s different attitude to the two clinical categories may have influenced the results. While pointing out this possible bias, we should also mention that since manual medicine can only be medically delivered by definition, [12] this should not change the pragmatic evaluation of the treatment package ‘as it is’. [18] The same considerations apply for the difference in duration of the first treatment (3 weeks for back school and individual, 4.3 weeks for spinal manipulation on average), although, since patients in our spinal manipulation group received a 1.2 week longer treatment than individual physiotherapy and back school, this must be acknowledged as a major limitation in the between-group comparisons in the short term. On the other hand, spinal manipulation would indeed be delivered across a wider timeframe, but the total amount of time devoted to treatment would be much less than either physiotherapy intervention (80–120 minutes vs. 15 hours altogether).
Our study design did not include a formal cost analysis and straightforward recommendations cannot be drawn from our data. However, we may be confident that individual physiotherapy’s costs were altogether higher than back school’s, since duration, frequency and number of sessions were the same, but the therapist:patient ratio was 1:4 in back school and 1:1 in individual physiotherapy. Thus, since back school appeared to provide a similar short-term and similar or better long-term outcome compared with individual physiotherapy at lower costs, our results seem in line with health policies promoting back school, and in general group physiotherapy with individualized exercise programmes, [2] rather than individual physiotherapy for most patients with chronic low back pain. [5, 24]
Such direct comparison is not possible for spinal manipulation versus physiotherapy. Spinal manipulation was associated with best results both in terms of pain and function, but long-term results were obtained at the price of returning more often for further treatment in the follow-up. Thus spinal manipulation seemed to be less effective than physiotherapy in promoting self-treatment. Furthermore, at least as far as manual medicine is concerned, spinal manipulation requires availability of specialized trained physicians in the ambulatory setting.
Observing changes within group, we found that, on discharge, patients assigned to all three groups reported on average a significant improvement in the primary functional outcome measure (Roland Morris Disability score) greater than 2.5 points. [19] Pain also improved significantly in all three groups. Compliance was very high: of the 210 participants recruited, only five interrupted treatment, evenly spread across groups, and none because of any adverse reaction or worsening of symptoms. In the long term, all interventions were significantly associated with maintained improvements in disability reports. Pain scores at one year remained significantly lower than baseline scores for back school and spinal manipulation, but not for individual physiotherapy. Working variables also improved in time across groups, but our home-dwelling Italian sample, mostly composed of women and also including elderly patients, had relatively few working participants, thus our numbers were too small to detect meaningful changes regarding working outcome.
Since our purpose was to compare already recommended interventions for chronic, non-specific low back pain, [25] at this stage we did not select a control group, so strictly we cannot claim effectiveness for either intervention considered. Furthermore, it should be mentioned that although we selected only patients who reported constant or almost constant low back pain in the past six months, recruitment actually followed a specialist’s consultation for the complaint of low back pain. It is reasonable to suppose that chronic patients required consultation when the symptoms exacerbated, [26, 27] and this may have added to the positive effects of all three interventions. [28] On the other hand, patients assigned to all three groups reported improvements in Roland Morris Disability score more than the 2.5-point difference that is regarded by many authors as clinically relevant in low back pain trials, [19] while pain improved in all three groups by 0.9–2.9 points out of 6. These results were better than the pooled mean improvement of 13.3 points (5.5–21.1) out of 100 for pain, 6.9 (2.2–11.7) out of 10 for function found in studies investigating the effects of exercise therapy on health care samples. [28] Furthermore, a recent systematic review of non-pharmacological therapies for chronic low back pain for an American Pain Society/American College of Physicians clinical practice guideline reported evidence of the effectiveness of cognitive-behavioural therapy, exercise, spinal manipulation and interdisciplinary rehabilitation, with benefits over placebo, sham therapy or no treatment that averaged 10–20 points on a 100-point visual analogue pain scale, 2–4 points on the Roland Morris Disability Questionnaire. [25]Again, for any of the three interventions considered in our study, short- and long–term pain relief and functional improvement were more relevant than those reported by this review.
Finally, considering that all our patients at baseline had complained of constant low back pain for at least six months, our 15–49% rate of patients across groups reporting no or rare low back pain recurrence over the last six months of the follow-up suggested that the effects of the three interventions were also clinically meaningful in the long term. [26, 29]
Other study limitations include the single-site study design, which reduces the generalizability of the results, and the lack of a control group, and of a structured baseline and follow-up assessment of psychological well-being, which might have added relevant information to our data. As recent evidence suggests that clustering low back pain patients with specific problems may predict best outcome of different treatment, [30, 31] it is possible that clustering our sample into subgroups with specific clinical characteristics and comparing a single intervention with a control group may further optimize the results.
Clinical messages
In chronic non-specific low back pain, spinal manipulation provided more functional improvement and pain relief, and reduced drug intake and recurrence rate than exercise therapy, though with more treatment at follow-up.
Compared with physiotherapy interventions, back school had similar short-term and better long-term outcome than individually delivered treatment.
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